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Phase III Randomized Trial of Concomitant Radiation, Cisplatin, and Tirapazamine Versus Concomitant Radiation and Cisplatin in Patients With Advanced Head and Neck Cancer


Phase 3
18 Years
N/A
Not Enrolling
Both
Head and Neck Squamous Cell Carcinoma

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Trial Information

Phase III Randomized Trial of Concomitant Radiation, Cisplatin, and Tirapazamine Versus Concomitant Radiation and Cisplatin in Patients With Advanced Head and Neck Cancer


Inclusion Criteria:



- Previously untreated squamous cell carcinoma of the oral cavity, oropharynx,
hypopharynx, or larynx.

- Stage III or IV disease (excluding T1N1, and T2N1 and metastatic disease).

- ECOG performance status less than or equal to 2.

- Absolute neutrophil count at least 1.5 X 10^9/L, platelet count at least 100 X
10^9/L, and hemoglobin > 9g/dL.

- Serum bilirubin < 1.25 times ULN and AST/ALT < 2.5 times ULN.

- Calculated creatinine clearance (Cockcroft-Gault) > 55 mL/min.

Exclusion Criteria:

- Metastatic Disease

- Primary cancers of the nasal and paranasal cavities and of the nasopharynx

- Significant intercurrent illness that will interfere with the Chemotherapy or
Radiation Therapy during the trial

- Symptomatic peripheral neuropathy > grade 2

- Clinically significant hearing impairment

- Significant cardiac disease

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

Study period

Safety Issue:

No

Principal Investigator

ICD CSD

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

EFC5512

NCT ID:

NCT00174837

Start Date:

April 2005

Completion Date:

January 2008

Related Keywords:

  • Head and Neck Squamous Cell Carcinoma
  • Tirapazamine
  • Head and Neck Cancer
  • Cisplatin
  • Radiation
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

Sanofi-Aventis Administrative OfficeBridgewater, New Jersey  08807